The new article highlights additional aspects related to the change notification process, including the turn-around time and fees.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to change notifications for medical devices that are already registered and placed on the market. The document describes the approach to be applied when notifying the authority about the changes made to a registered device and explains how the changes should be evaluated to determine their regulatory status. The guidance is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, and in case of any discrepancies with provisions of the underlying legislation, the latter should prevail.
Change Notification Turn-Around-Time (TAT)
First of all, the authority emphasizes that the dossier submitted should be complete and contain all the important information as required under the applicable regulatory requirements. Should the submitted dossier be incomplete, and/or the applicant fails to provide additional information requested by the HSA within the appropriate time frame, the overall review process could be delayed.
According to the guidance, TAT depends on the risk classification of the product in question, and also on the type of changes (e.g., review, administrative, or technical).
For example, in the case of technical changes to Class D products, which are considered to be high-risk, the overall time is 90 business days, while the shortest period is for administrative changes – it constitutes 30 business days irrespectively of the device class.
As further explained by the HSA, the TAT calculation should be commenced from the date when the dossier has been initially submitted to the authority for review, while the periods when the authority has been waiting for the applicant to provide additional information should be excluded from the calculation. In case the changes covered by the scope of a single application fall within the multiple categories, the timeline for the highest category should be applied. The authority provides an example when the application describes both administrative and technical changes – in such a case, the timeline for technical changes should be applied. It is also stated that the timeline should be calculated for each application separately.
Change Notification Fees
As it was mentioned before, the change notification applications are subject to a special fee payable by the applicant. In the case of multiple categories of changes included within the same application, the highest applicable rate should be applied (actually, the approach should be similar to the one applied when determining the review timeframe). The authority also states that the fees described herein are non-refundable, hence, in case the change notification application will be rejected or withdrawn, the fees paid by the applicant would not be returned.
Change Notification Requirements
Apart from the aforementioned aspects, the document also contains annexes providing additional clarifications regarding the change notification submission requirements. For instance, one of the annexes describes the approach to be applied when determining the scope of information and documentation to be included in the submission dossier depending on the type of changes in question. As it is stated in the guidance, should any of the documents be unavailable, the appropriate justification should be duly provided by the applicant.
The document further outlines the specific documents to be submitted depending on the type and category of changes. The changes covered by the scope of the guidance include the ones related to:
- Manufacturing and/or sterilization facilities;
- Manufacturing or refurbishing processes;
- Sterilization methods used;
- Control mechanisms, operating principles, packaging or design;
- Specifications of a registered medical device (e.g., shelf life, stability, expiry date);
- Type, source, processing, and/or supplier of biological materials;
- Material and formulation, including the changes to the materials used for shielding in radiation-emitting devices;
- Drug concentration or specification (for the medical devices incorporating medicines – device-drug combination products);
- Labeling (including the ones that are related to changes to the intended use).
Apart from the above mentioned changes, the document describes the approach to be applied in the use of the addition of new medical devices or models; or the removal thereof, as well as changes to the product owner or its details.
Depending on the changes, the documents the authority will expect to receive may include, inter alia, the following ones:
- ISO 13485 certificate related to the Quality Management System;
- Sterilization validation report;
- Summary of the new manufacturing process;
- Design verification and validation documents;
- Risk analysis;
- Clinical evidence;
- A detailed summary of changes to the software;
- Biological safety data;
- List of material(s) making direct/indirect contact with the human body;
- Information on radiation source;
- Device labeling with changes that are highlighted/identified and finalized device labeling.
Summary Table of Change Notification
The document also provides recommendations regarding the summary table of changes to be submitted together with the Change Notification application for all types of changes. The said table should contain information about any changes to the device in question. The information should be detailed enough to make it possible for the authority to assess the safety- and performance-related matters associated with the changes.
The table should include the following elements:
- Type of changes, including the indication of the type of change, category of change, and listing number of a medical device in question;
- Present – the information about the initial medical device and aspects subject to changes;
- A proposed – detailed description of changes to be made;
- Reason for change – justification of changes;
- Status of a proposed change in reference agencies – details about the approvals granted by other national regulating authorities concerning the changes suggested;
- A check-box indicating whether the changes are related to the ongoing field safety corrective action.
In summary, the present HSA guidance describes in detail existing regulatory requirements for the Change Notification application and highlights the most important aspects associated thereto. The document outlines the key elements such an application should contain, and also explains the way the application should be submitted.
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